Iron Fortified Beverages and Application in Women Predisposed to Anemia (FeDrink)

• The objective of the study is to know if consumption of an iron fortified fruit juice containing micronized iron pyrophosphate, is useful to increase iron status in women predisposed to iron deficiency anemia.
• A secondary objective is to know if consumption of this iron fortified fruit juice modifies bone remodelling.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency Anemia
• Intervention / Treatment: Dietary supplement: non-fortified fruit juices consumed as part of the usual diet; Dietary supplement: Iron fortified fruit juice

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women
• non-smoker
• non-pregnant
• non-breastfeeding
• serum ferritin <40 ng/ml
• hemoglobin>=11g/dl

Exclusion Criteria:

• Serum Ferritin >=40 ng/ml
• Hemoglobin <11g/dl
• Amenorrhea
• Menopause
• Iron deficiency anemia
• Thalassemia
• Hemochromatosis
• Blood donors
• Chronic gastric diseases
• Renal diseases
• Eating disorders
• Allergy to any component of the study juices
• Consumption of iron or ascorbic acid supplements within 4 month prior to participating in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo juices; Consumption of non-iron fortified fruit juices as part of the usual diet	Dietary supplement: non-fortified fruit juices consumed as part of the usual diet
Experimental: Iron fortified fruit juices; Consumption of iron fortified fruit juices as part of the usual diet	Dietary supplement: Iron fortified fruit juice; Consumption of micronized iron pyrophosphate supplemented fruit juices as part of the usual diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum Ferritin	monitored during 16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum transferrin	monitored during 16 weeks
Hemoglobin	monitored during 16 weeks
serum iron	monitored during 16 weeks
transferrin saturation	monitored during 16 weeks
soluble transferrin receptor	monitored during 16 weeks
zinc protoporphyrin	monitored during 16 weeks
Total red blood cells	monitored during 16 weeks
Hematocrit	monitored during 16 weeks
Mean corpuscular volume	monitored during 16 weeks
Red blood cell distribution width	monitored during 16 weeks
25-hydroxycholecalciferol	monitored during 16 weeks
alkaline phosphatase bone-isoenzyme (ALP)	monitored during 16 weeks
serum cross-linked N-telopeptide of type I collagen (NTx)	monitored during 16 weeks
Total cholesterol	monitored during 16 weeks
HDL-cholesterol	monitored during 16 weeks
LDL-cholesterol	monitored during 16 weeks
Glucose	monitored during 16 weeks
Serum triacylglycerols	monitored during 16 weeks
T-chol/HDL-chol	monitored during 16 weeks
LDL-chol/HDL-chol	monitored during 16 weeks
Systolic blood pressure	monitored during 16 weeks
Diastolic blood pressure	monitored during 16 weeks

Collaborators and Investigators

• Sponsor: National Research Council, Spain
• Collaborators: Ministry of Science and Innovation, Spain; Grupo Leche Pascual; Madrid Salud, Madrid, Spain

Publications and helpful links

General Publications

• Navas-Carretero S, Perez-Granados AM, Schoppen S, Sarria B, Carbajal A, Vaquero MP. Iron status biomarkers in iron deficient women consuming oily fish versus red meat diet. J Physiol Biochem. 2009 Jun;65(2):165-74. doi: 10.1007/BF03179067.
• Navas-Carretero S, Perez-Granados AM, Schoppen S, Vaquero MP. An oily fish diet increases insulin sensitivity compared to a red meat diet in young iron-deficient women. Br J Nutr. 2009 Aug;102(4):546-53. doi: 10.1017/S0007114509220794. Epub 2009 Feb 12.
• Navas-Carretero S, Perez-Granados AM, Sarria B, Vaquero MP. Iron absorption from meat pate fortified with ferric pyrophosphate in iron-deficient women. Nutrition. 2009 Jan;25(1):20-4. doi: 10.1016/j.nut.2008.07.002. Epub 2008 Aug 26.
• Navas-Carretero S, Perez-Granados AM, Sarria B, Carbajal A, Pedrosa MM, Roe MA, Fairweather-Tait SJ, Vaquero MP. Oily fish increases iron bioavailability of a phytate rich meal in young iron deficient women. J Am Coll Nutr. 2008 Feb;27(1):96-101. doi: 10.1080/07315724.2008.10719680.
• Navas-Carretero S, Sarria B, Perez-Granados AM, Schoppen S, Izquierdo-Pulido M, Vaquero MP. A comparative study of iron bioavailability from cocoa supplemented with ferric pyrophosphate or ferrous fumarate in rats. Ann Nutr Metab. 2007;51(3):204-7. doi: 10.1159/000104138. Epub 2007 Jun 18.
• Sarria B, Navas-Carretero S, Lopez-Parra AM, Perez-Granados AM, Arroyo-Pardo E, Roe MA, Teucher B, Vaquero MP, Fairweather-Tait SJ. The G277S transferrin mutation does not affect iron absorption in iron deficient women. Eur J Nutr. 2007 Feb;46(1):57-60. doi: 10.1007/s00394-006-0631-x. Epub 2007 Jan 5.
• Toxqui L, De Piero A, Courtois V, Bastida S, Sanchez-Muniz FJ, Vaquero MP. [Iron deficiency and overload. Implications in oxidative stress and cardiovascular health]. Nutr Hosp. 2010 May-Jun;25(3):350-65. Spanish.
• Blanco-Rojo R, Perez-Granados AM, Toxqui L, Zazo P, de la Piedra C, Vaquero MP. Relationship between vitamin D deficiency, bone remodelling and iron status in iron-deficient young women consuming an iron-fortified food. Eur J Nutr. 2013 Mar;52(2):695-703. doi: 10.1007/s00394-012-0375-8. Epub 2012 May 23.
• Blanco-Rojo R, Perez-Granados AM, Toxqui L, Gonzalez-Vizcayno C, Delgado MA, Vaquero MP. Efficacy of a microencapsulated iron pyrophosphate-fortified fruit juice: a randomised, double-blind, placebo-controlled study in Spanish iron-deficient women. Br J Nutr. 2011 Jun;105(11):1652-9. doi: 10.1017/S0007114510005490. Epub 2011 Feb 8.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: May 28, 2010
• First Submitted That Met QC Criteria: June 2, 2010
• First Posted (Estimate): June 3, 2010

Study Record Updates

• Last Update Posted (Estimate): December 24, 2012
• Last Update Submitted That Met QC Criteria: December 21, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Women; Bioavailability; Functional food; iron status; iron-deficiency anemia; Fortification; Ferric pyrophosphate; Fruit juice
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia
• Other Study ID Numbers: AGL2006/09519/ALI